A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- percentage of patients achieving target dose
研究概览
简要总结
This study is to test the feasibility and tolerability of the metoprolol optimal dosing pathway by observing the percentage of patients achieving target dose followed the pathway on ACS patients during hospitalization.
详细描述
Acute coronary syndrome(ACS) is one of the main manifestations of cardiovascular disease and one of the main causes for hospitalization in adults.
Previous studies showed that β-receptor blockers can reduce ACS patients' cardiovascular risk in both acute phase and secondary prevention. We summarized the metoprolol optimal dosing pathway based on Chinese and foreign guidelines as well as Chinese clinical practice.
Primary endpoint is the percentage of patients achieving target dose at time of discharge.
Secondary endpoints are the mean HR & BP at discharge and during the follow up period of the Patients who have achieved target dose at discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or above;
- •Hospitalized due to acute coronary syndrome;
- •Able and willing to provide written informed consent and to comply with the study.
排除标准
- •Cardiac shock;
- •Unstable heart failure;
- •Beta-agonist therapy on a continuous or intermittent basis;
- •Hypotension (BP<90/60 mmHg) or bradycardia (HR<50 bpm) with symptoms;
- •Sick sinus syndrome;
- •Ⅱ~Ⅲ atrioventricular block;
- •Killip >Ⅱ;
- •Suspected acute myocardial infarction with heart rate<45 beats/min, P- R interval>0.24 sec or systolic blood pressure <100 mmHg;
- •Existing contraindication for metoprolol or allergic to metoprolol or any excipients;
- •Participation in another clinical study with an investigational product during the last 3 months;
- •Previous enrolment in the present study;
- •Subjects the investigator thinks not suitable for this study. E.g. cancer etc.;
- •Inability to sign the informed consent form;
- •Pregnancy or lactation.
研究组 & 干预措施
Metoprolol interventional group
This is a multi-center, prospective, open label, single-arm interventional study.
Patients hospitalized for ACS, fulfilling all of the inclusion criteria and none of the exclusion criteria can be enrolled in this study.
干预措施: Metoprolol (Drug)
结局指标
主要结局
percentage of patients achieving target dose
时间窗: 1 month
The percentage of patients achieving target dose of 95mg/d at the time of discharge
次要结局
- mean heart rate(1 month)
- mean blood pressure(1 month)
- percentage of patients who experienced bradycardia with symptoms(1 month)
研究者
Yun Dai Chen
MD
Chinese PLA General Hospital